SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 27, 2011
ARQULE, INC.
(Exact Name of Issuer as Specified in Charter)
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Delaware |
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000-21429 |
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04-3221586 |
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(State or other jurisdiction |
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(Commission File Number) |
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(I.R.S. Employer |
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of incorporation) |
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Identification No.) |
19 Presidential Way
Woburn, MA
(Address of principal executive offices)
01801
(Zip code)
(781) 994-0300
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Section 5 — Other Events
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(d) On April 27, 2011, Susan L. Kelley, M.D. was appointed to the Board of Directors of ArQule, Inc. (the “Registrant”). Dr. Kelley will serve on the Registrant’s Board of Directors until its 2013 Annual Meeting of Stockholders, at which time the Registrant anticipates that Dr. Kelley will be nominated to serve for an additional term. There was no arrangement or understanding between Dr. Kelley and the Registrant (or any other person known to the Registrant) pursuant to which Dr. Kelley was appointed. Dr. Kelley has been appointed to the Science Committee of the Board of Directors.
Under the Registrant’s Amended and Restated 1996 Director Stock Option Plan upon election as a director Dr. Kelley was automatically granted an option to purchase 30,000 shares of the Registrant’s common stock. This option becomes exercisable as to 10,000 shares on the date of each of the Registrant’s next three annual meeting of stockholders following the date of grant. Should she continue to serve on the Registrant’s board immediately after each annual meeting of stockholders she will receive an automatic grant of an option to purchase 15,000 shares of common stock. This option will be fully exercisable on the date of grant. All options referred to in this paragraph have a term of ten years and an exercise price equal to the closing price of the Registrant’s common stock as reported by the NASDAQ Stock Market on the date of grant.
As a non-employee director, if Dr. Kelley is serving as a director prior to and immediately following any annual meeting of the Registrant’s stockholders, she will receive a $20,000 annual retainer. She will also receive $2,000 for each day she attends a meeting of directors and $1,000 for each day on which a committee of the Board meets and she attends. Under the Registrant’s 2005 Director Stock Compensation Plan, Dr. Kelley, as a non-employee director, may elect to receive all or part of her compensation for service as a director in the form of the Registrant’s common stock in lieu of such cash fees.
From 2001 to 2008, Dr. Kelley was employed by Bayer Healthcare Pharmaceuticals and Bayer- Schering Pharma in Germany and the United States serving as Vice President, Global Strategic Drug Development, Cancer and Metabolics from April 2001 to May 2002 and from May 2002 until June 2008 as Vice President, Global Clinical Development and Therapeutic Area Head-Oncology. From July 2008 to March 2011, she was Chief Medical Officer of The Multiple Myeloma Research Foundation/Consortium. Most recently, she has been an independent consultant to the pharmaceutical and biotechnology industries in the field of oncology drug development and strategy.
Section 9 — Financial Statements and Exhibits
Item 9.01. Financial Statements and Exhibits.
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(d) Exhibits. |
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Exhibit No. 99.1 |
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Text of press release announcing appointment of director dated April 28, 2011. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ARQULE, INC. |
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(Registrant) |
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/s/ Peter S. Lawrence |
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Peter S. Lawrence |
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President and Chief Operating Officer |
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April 28, 2011 |
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Exhibit 99.1
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Contact: |
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William B. Boni |
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VP, Investor Relations/ |
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Corp. Communications |
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(781) 994-0300 |
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www.ArQule.com |
For Immediate Release:
ARQULE, INC. ANNOUNCES APPOINTMENT OF DR. SUSAN KELLEY
TO BOARD OF DIRECTORS
Woburn, MA, April 28, 2011 — ArQule, Inc. (Nasdaq: ARQL) today announced the appointment of Susan L. Kelley, M.D. to its board of directors, effective April 27, 2011.
Dr. Kelley is currently an independent consultant to the pharmaceutical and biotechnology industries in the field of oncology drug development and strategy. From 2008 to 2011, she was Chief Medical Officer of the Multiple Myeloma Research Consortium and its sister organization, the Multiple Myeloma Research Foundation, where her responsibilities spanned the continuum of clinical drug development from translational research and clinical trials to FDA regulatory compliance.
From 2001 to 2008, Dr. Kelley was employed by Bayer Healthcare Pharmaceuticals and Bayer-Schering Pharma as Vice President, Global Clinical Development and Therapeutic Area Head — Oncology. Dr. Kelley worked at Bristol-Myers Squibb Company from 1987 to 2001, most recently as Executive Director, Oncology Clinical Research, at the Bristol-Myers Squibb Pharmaceutical Research Institute.
Dr. Kelley received her M.D. from Duke University School of Medicine and an A.B. in biology, magna cum laude, from Colgate University. She was a Fellow in Medical Oncology and Clinical Fellow in Medicine at Dana-Farber Cancer Institute, Harvard Medical School, and a Fellow in Medical Oncology and Pharmacology at Yale University School of Medicine, where she also served as a Clinical Assistant Professor of Medicine.
“Dr. Kelley brings strong clinical development skills and regulatory experience to the ArQule board of directors as the Company’s lead product, tivantinib, progresses in its Phase 3 trial in non-small cell lung cancer,” said Patrick J. Zenner, chairman of the board of ArQule. “We welcome her to the board and look forward to her contributions to the advancement of tivantinib and other pipeline products that are directed toward promising therapeutic targets in oncology.”
About ArQule
ArQule is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics. The Company’s targeted, broad-spectrum products and research programs are focused on key biological processes that are central to
human cancers. ArQule’s lead product, in Phase 2 and Phase 3 clinical development, is tivantinib (ARQ 197), an inhibitor of the c-Met receptor tyrosine kinase. The Company has also initiated Phase 1 clinical testing with ARQ 621, designed to inhibit the Eg5 kinesin motor protein, and with ARQ 736, designed to inhibit the RAF kinases. ArQule’s current discovery efforts, which are based on the ArQule Kinase Inhibitor Platform (AKIP™), are focused on the identification of novel kinase inhibitors that are potent, selective and do not compete with ATP (adenosine triphosphate) for binding to the kinase.
This press release contains forward-looking statements regarding the Company’s clinical trials with tivantinib (ARQ 197) and other candidate compounds in earlier stages of development. These statements are based on the Company’s current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. Positive information about pre-clinical and early stage clinical trial results does not ensure that later stage or larger scale clinical trials will be successful. For example, tivantinib and the Company’s earlier-stage compounds may not demonstrate promising therapeutic effects; in addition, they may not demonstrate appropriate safety profiles in current or later stage or larger scale clinical trials as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards or to justify further development. Problems or delays may arise during clinical trials or in the course of developing, testing or manufacturing these compounds that could lead the Company or its partners to discontinue development. Even if later stage clinical trials are successful, unexpected concerns may arise from analysis of data or from additional data. Obstacles may arise or issues may be identified in connection with review of clinical data with regulatory authorities and regulatory authorities may disagree with the Company’s view of the data or require additional data or information or additional studies. In addition, the planned timing of initiation and completion of clinical trials for tivantinib are subject to the ability of the Company or Daiichi Sankyo, Inc., its partner, and Kyowa Hakko Kirin, a licensee of tivantinib, to enroll patients, enter into agreements with clinical trial sites and investigators, and overcome other technical hurdles and issues related to the conduct of the trials for which each of them is responsible that may not be resolved. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Positive pre-clinical data may not be supported in later stages of development. Furthermore, ArQule may not have the financial or human resources to successfully pursue drug discovery in the future. Moreover, Daiichi Sankyo has certain rights to unilaterally terminate the tivantinib license, co-development and co-commercialization agreement. If it were to do so, the Company might not be able to complete development and commercialization of tivantinib on its own. For more detailed information on the risks and uncertainties associated with the Company’s drug development and other activities, see the Company’s periodic reports filed with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements.
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